Lifestyle Program for Breast Cancer

MM
Overseen ByMeroe Morse, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a lifestyle program can best support women with HR+/HER2- metastatic breast cancer. It tests three approaches: the Group-based Comprehensive Lifestyle Program alone, the program with group support, and the program with both group support and personal health coaching. Women with this type of cancer who are currently undergoing treatment and have access to a smartphone or computer might be suitable candidates. The trial particularly targets those who consume little fruit and vegetables or are not very active. As an unphased trial, it offers a unique opportunity to explore personalized lifestyle interventions that could enhance well-being alongside current treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems focused on lifestyle changes rather than medication changes.

What prior data suggests that this lifestyle program is safe for breast cancer patients?

Research has shown that lifestyle programs like the ACLP are generally safe and easy to follow. These programs help individuals improve their diet, exercise habits, and stress management. For instance, one study found that participants in a lifestyle program lost a moderate amount of weight. Another study suggested these programs benefit breast cancer patients without causing major side effects. Overall, evidence supports the safety of these programs for people with breast cancer.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a holistic approach to managing breast cancer that goes beyond traditional medical interventions like surgery, chemotherapy, and radiation. The Comprehensive Lifestyle Program (ACLP) is unique because it combines group-based learning and support, which can foster a sense of community and shared experience among participants. The addition of Learning Circles enhances this by providing a space for participants to gain insights and motivation from peers, while the Individual Health Coaching tailors the program to each participant's specific needs, offering personalized guidance and support. This multi-faceted approach aims to improve overall well-being, potentially leading to better health outcomes for those living with breast cancer.

What evidence suggests that this lifestyle program is effective for breast cancer?

Studies have shown that lifestyle programs can positively affect breast cancer outcomes. Research indicates that changes like eating healthier and exercising regularly can lower the chances of cancer recurrence and extend life expectancy. One study found that these lifestyle changes led to moderate weight loss, benefiting breast cancer survivors. Another study demonstrated that these lifestyle and behavior changes improved patients' quality of life. This trial will evaluate the ACLP (comprehensive lifestyle program) in different formats. Participants may engage in the ACLP alone, in combination with Learning Circles, or with both Learning Circles and Individual Health Coaching. Overall, this evidence suggests that the ACLP could improve health outcomes for people with breast cancer.16789

Who Is on the Research Team?

MM

Meroe Morse, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with HR+/HER2- metastatic breast cancer on first or second-line treatment. Participants must have a life expectancy of at least 12 months, speak English, and be able to follow the study plan. They should eat less than three servings of fruits/veggies per day, exercise under 150 minutes weekly, practice mind-body activities less than four times a month, and have internet access.

Inclusion Criteria

Life expectancy at least 12 months
Able to read, write, and speak English
Willingness to follow protocol requirements
See 9 more

Exclusion Criteria

Poorly-controlled or uncontrolled diabetes in the opinion of the physician(s)
Any major thought disorder (e.g., schizophrenia, dementia)
Communication barriers (e.g., hard of hearing)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups to complete the ACLP program with or without additional support over 8 weeks

8 weeks
Weekly online sessions

Individual Health Coaching

Participants in the ACLP-LC-IHC group receive individual health coaching sessions starting two weeks after the end of the main program

3 months
Up to 6 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Follow-up at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Group-based Comprehensive Lifestyle Program
Trial Overview The trial studies how well an ACLP (group-based comprehensive lifestyle program) supports patients with stable HR+/HER2- metastatic breast cancer. It involves surveys about demographics and lifestyle to understand patient needs better.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: ACLP Program + Learning Circles + Individual Health CoachingExperimental Treatment1 Intervention
Group II: ACLP Program + Learning CirclesExperimental Treatment1 Intervention
Group III: ACLP ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Group-based Comprehensive Lifestyle Program for ...It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...
The effects of lifestyle and behavioural interventions on ...This study aimed to assess and compare the effects of lifestyle/behavioural interventions on cancer recurrence, survival and QoL in breast cancer survivors.
Lifestyle modifications for patients with breast cancer to ...We review the role of lifestyle factors, particularly weight management, exercise, diet, smoking, alcohol intake and vitamin supplementation, on the prognosis ...
Effect of a comprehensive lifestyle intervention program on ...The results of this study show that a 24-month, individualized, telephone-delivered lifestyle intervention led to a moderate weight loss of 3–4% ...
Preliminary efficacy of a community-based, group- ...The purpose of this study is to determine the preliminary efficacy of a community-based LWM intervention in BCa survivors on select body composition (BC), ...
Evidence for the benefits of lifestyle medicine interventions in ...Data presented here suggest that patients living with breast cancer would benefit from a comprehensive lifestyle medicine approach to ...
Effect of a comprehensive lifestyle intervention program on ...The results of this study show that a 24-month, individualized, telephone-delivered lifestyle intervention led to a moderate weight loss of 3–4% in women with ...
Lifestyle medicine program for patients with breast cancer ...The KPEB Lifestyle Medicine Program is founded on evidence-based interventions focusing on nutrition, physical activity, stress management, sleep, substance ...
Lifestyle Program for Breast Cancer · Info for Participants... Group-based Comprehensive Lifestyle Program will have tolerable side effects & efficacy for patients with Breast Cancer and Breast Cancer. Learn more about the
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